U.S. patent application number 17/366590 was filed with the patent office on 2021-10-28 for hand crank manually driven intraosseous injection devices and methods.
The applicant listed for this patent is TELEFLEX LIFE SCIENCES LIMITED. Invention is credited to Aleksejus FOMINAS, Eugene SKELTON, Morgan TIERNEY, Anthony WRIGHT.
Application Number | 20210330337 17/366590 |
Document ID | / |
Family ID | 1000005735474 |
Filed Date | 2021-10-28 |
United States Patent
Application |
20210330337 |
Kind Code |
A1 |
TIERNEY; Morgan ; et
al. |
October 28, 2021 |
HAND CRANK MANUALLY DRIVEN INTRAOSSEOUS INJECTION DEVICES AND
METHODS
Abstract
Manually driven intraosseous devices and associated methods are
disclosed. The intraosseous device includes a housing and a
transmission at least partially disposed within the housing. The
transmission includes a first portion and a second portion. The
second portion includes a manual actuator that is at least
partially disposed outside of the housing. The intraosseous device
also includes a penetrator assembly releasably connected to the
first portion of the transmission. The transmission is configured
to transmit a force, which is applied manually to the manual
actuator, to the penetrator assembly to rotate the penetrator
assembly relative to the housing and to drive the penetrator
assembly through a bone into an intraosseous space. The manual
actuator is a hand crank that is configured to be manually cranked
by an operator to transfer rotational force to the first portion of
the transmission.
Inventors: |
TIERNEY; Morgan; (Ferbane,
IE) ; FOMINAS; Aleksejus; (Athlone, IE) ;
SKELTON; Eugene; (Cabinteely, IE) ; WRIGHT;
Anthony; (Dungarvan, IE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
TELEFLEX LIFE SCIENCES LIMITED |
Valletta |
|
MT |
|
|
Family ID: |
1000005735474 |
Appl. No.: |
17/366590 |
Filed: |
July 2, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
PCT/IB2019/061292 |
Dec 23, 2019 |
|
|
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17366590 |
|
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62788226 |
Jan 4, 2019 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/1624
20130101 |
International
Class: |
A61B 17/16 20060101
A61B017/16 |
Claims
1. An intraosseous device comprising: a housing; a transmission at
least partially disposed within the housing, the transmission
including a first portion and a second portion, the second portion
including a manual actuator that is at least partially disposed
outside of the housing; and a penetrator assembly releasably
connected to the first portion of the transmission, wherein the
transmission is configured to transmit a force, which is applied
manually to the manual actuator, to the penetrator assembly to
rotate the penetrator assembly relative to the housing and to drive
the penetrator assembly through a bone into an intraosseous
space.
2. The intraosseous device according to claim 1, wherein the manual
actuator is a hand crank that is configured to be manually cranked
by an operator to transfer rotational force to the first portion of
the transmission.
3. The intraosseous device according to claim 2, wherein the hand
crank includes a first end, a second end, and an arm extending
between the first end and the second end.
4. The intraosseous device according to claim 3, wherein the first
end of the hand crank includes a handle.
5. The intraosseous device according to claim 3, wherein the second
end of the hand crank includes a cylinder having a top, a bottom,
and an outer circumferential surface extending between the top and
the bottom.
6. The intraosseous device according to claim 5, wherein the second
portion of the transmission includes a gear that is configured to
mesh with a gear of the first portion of the transmission to
transmit the force between the hand crank and the first portion of
the transmission.
7. The intraosseous device according to claim 1, wherein the first
portion of the transmission includes a shaft having a first end
that is configured to connect to the penetrator assembly.
8. The intraosseous device according to claim 7, wherein the first
end of the shaft is keyed.
9. The intraosseous device according to claim 7, wherein a magnet
is embedded in the first end of the shaft.
10. The intraosseous device according to claim 1, wherein the first
portion of the transmission or the penetrator assembly is provided
through at least one tubular bearing of the housing so as to be
rotatable relative to the housing.
11. The intraosseous device according to claim 1, wherein the first
portion of the transmission is configured to interface with the
second portion of the transmission such that the second portion of
the transmission is configured to rotate the second end of the
shaft.
12. The intraosseous device according to claim 7, wherein the
second end of the shaft includes a gear.
13. The intraosseous device according to claim 7, wherein the first
portion of the transmission further includes a support plate held
within a chamber of the housing, and the support plate supports the
second end of the shaft.
14. The intraosseous device according to claim 1, wherein the
housing is divided into a first body and a second body that are
snap fit together.
15. The intraosseous device according to claim 14, wherein the
housing comprises bearings that support the first portion and the
second portion of the transmission such that the first portion and
the second portion of the transmission are configured to rotate
relative to the housing.
16. The intraosseous device according to claim 15, wherein the
bearings are integral with the housing.
17. The intraosseous device according to claim 15, wherein the
bearings comprise at least one tubular bearing.
18. The intraosseous device according to claim 17, wherein the at
least one tubular bearing is one of a plurality of tubular
bearings, the plurality of tubular bearings each include an inner
circumferential surface, the plurality of tubular bearings are each
arranged coaxially along a linear direction extending through the
housing, and the inner circumferential surface of each of the
plurality of tubular bearings support the first portion of the
transmission such that the first portion of the transmission is
configured to rotate relative to the housing.
19. The intraosseous device according to claim 18, wherein an inner
diameter of the inner circumferential surface of each of the
plurality of tubular bearings is larger than an outer diameter of
the first portion of the transmission such that the first portion
of the transmission is configured to extend through the plurality
of tubular bearings.
20. A method of accessing an intraosseous space of a patient
comprising: providing an intraosseous device according to claim 1;
driving the penetrator assembly through a bone into the
intraosseous space of the patient comprising: manually applying a
first force to the housing, the first force directing the
intraosseous device towards an insertion site on the patient; and
manually applying a second force, concurrently with manually
applying the first force, to the second portion of the transmission
and transmitting the second force to the penetrator assembly to
rotate the penetrator assembly relative to the housing.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a Continuation of International Patent
Application PCT/IB2019/061292, filed Dec. 23, 2019, which claims
the benefit of U.S. Provisional Patent Application No. 62/788,226,
filed Jan. 4, 2019. The disclosures of which are hereby
incorporated by reference in their entirety
TECHNICAL FIELD
[0002] This application relates generally to systems, devices, and
methods for intraocular injection.
BACKGROUND
[0003] Every year, patients around the world are treated for
life-threatening emergencies. Such life-threatening emergencies
include, for example, shock, trauma, cardiac arrest, drug
overdoses, diabetic ketoacidosis, arrhythmias, burns, and status
epilepticus. According to one study, more than 1.5 million patients
suffer from heart attacks (myocardial infarctions) each year, with
over 500 thousand of those patients dying from complications
arising from the heart attacks. Military, remote, and/or rural
environments may present unique challenges for treatment of
life-threatening injuries. Many patients die unnecessarily because
intravenous (IV) access cannot be achieved in a timely manner.
[0004] An essential element for treating many of the
above-described life-threatening emergencies is rapid establishment
of an IV line to administer drugs and fluids directly into a
patient's vascular system. Whether in an ambulance by paramedics,
in an emergency room by emergency specialists, in a remote or rural
area by a first-responder, or on a battlefield by a medic, the goal
is the same--quickly start an IV to administer lifesaving drugs and
fluids. To a large degree, the ability to successfully treat most
critical emergencies is dependent on the skill and/or luck of an
operator to rapidly access the vascular system. While it is
relatively easy to start an IV on some patients, medical
professionals often experience significant difficulty establishing
IV access for a number of patients, for whom the success rate of IV
establishment is particularly low. In addition to the risk to life
and limb, failed attempts to establish an IV can lead to
unnecessary pain to patients being probed.
[0005] In the case of patients with chronic disease or the elderly,
availability of easily accessible veins may be depleted. Other
patients may have no available IV sites due to anatomical scarcity
of peripheral veins, obesity, extreme dehydration or previous IV
drug use. For such patients, finding a suitable site for
administering lifesaving therapy often becomes a monumental and
frustrating task. While morbidity and mortality statistics are not
generally available, it is generally known that many patients with
life threatening emergencies have died because access to the
vascular system with lifesaving IV therapy was delayed or simply
not possible.
[0006] The intraosseous (IO) space provides a direct conduit to the
vascular system and provides an attractive alternate route for the
administration of IV drugs and fluids. Drugs and/or fluid
administered into an IO space enter the blood circulation system at
least as rapidly as when administered intravenously. Accordingly,
bone marrow may be an analog of a large, non-collapsible vein. IO
infusion has long been the standard of care in pediatric
emergencies when rapid IV access is not possible.
SUMMARY
[0007] The present inventors recognize that there is a need to
improve one or more features of IO injection devices and methods.
For example, there exists a need for IO injection devices that are
manually driven and have a low cost of production for use as an
alternative to IV access in emergent, urgent, or medically
necessary cases.
[0008] An aspect of the various embodiments of the invention is
directed to an intraosseous device. The intraosseous device
includes a housing and a transmission at least partially disposed
within the housing. The transmission includes a first portion and a
second portion. The second portion may include a manual actuator
that is at least partially disposed outside of the housing. The
intraosseous device further includes a penetrator assembly
releasably connected to the first portion of the transmission. The
transmission is configured to transmit a force, which is applied
manually to the manual actuator, to the penetrator assembly to
rotate the penetrator assembly relative to the housing and to drive
the penetrator assembly through a bone into an intraosseous
space.
[0009] Another aspect of the present invention includes a method of
accessing an intraosseous space of a patient. The method includes
providing an intraosseous device comprising a housing and a
transmission at least partially disposed within the housing. The
transmission includes a first portion and a second portion. The
provided intraosseous device further includes a penetrator assembly
releasably connected to the first portion of the transmission. The
method also includes driving the penetrator assembly through a bone
into the intraosseous space of the patient. Driving the penetrator
assembly through the bone into the intraosseous space of the
patient includes manually applying a first force to the housing,
where the first force directs the intraosseous device towards an
insertion site on the patient. Driving the penetrator assembly
through the bone into the intraosseous space of the patient further
includes manually applying a second force, concurrently with
manually applying the first force, to the second portion of the
transmission and transmitting the second force to the penetrator
assembly to rotate the penetrator assembly relative to the
housing.
[0010] There are, of course, additional aspects of the various
embodiments of the invention disclosed herein that will be
described below and which will form the subject matter of the
claims. In this respect, before explaining at least one aspect of
the invention in detail, it is to be understood that the invention
is not limited in its application to the details of construction
and to the arrangements of the components set forth in the
following description or illustrated in the drawings. The invention
is capable of aspects in addition to those described and of being
practiced and carried out in various ways. Also, it is to be
understood that the phraseology and terminology employed herein, as
well as the Abstract, are for the purpose of description and should
not be regarded as limiting.
[0011] As such, those skilled in the art will appreciate that the
conception upon which this invention is based may readily be
utilized as a basis for the designing of other structures, methods,
and systems for carrying out the several purposes of the invention.
It is important, therefore, that the claims be regarded as
including such equivalent constructions insofar as they do not
depart from the spirit and scope of the invention.
BRIEF DESCRIPTION OF DRAWINGS
[0012] In order that the invention may be readily understood,
aspects of the invention are illustrated by way of examples in the
accompanying drawings; however, the subject matter is not limited
to the disclosed aspects.
[0013] FIGS. 1A and 1B respectively illustrate a prospective and an
exploded view of an exemplary embodiment of the intraosseous device
in accordance with aspects of the invention.
[0014] FIGS. 2A-2C respectively illustrate side views of first and
second bodies of the housing and of the hand crank in accordance
with aspects of the invention.
[0015] FIGS. 3A-3C illustrate embodiments of the intraosseous
device including a plurality of exemplary housings in accordance
with aspects of the invention.
[0016] FIG. 4 illustrates a prospective view of another exemplary
embodiment of the intraosseous device in accordance with aspects of
the invention.
[0017] FIG. 5 illustrates a side exploded view of the other
exemplary embodiment of the intraosseous device in accordance with
aspects of the invention.
[0018] FIGS. 6A and 6B illustrate side views showing the interiors
of first and second bodies of the housing of the other exemplary
embodiment of the intraosseous device in accordance with aspects of
the invention.
[0019] FIGS. 7A and 7B show views of the transmission of the other
exemplary embodiment of the intraosseous device in accordance with
aspects of the invention.
[0020] FIGS. 8A-8C illustrate views of an exemplary penetrator
assembly of intraosseous devices in accordance with aspects of the
invention.
[0021] FIG. 9 illustrates an exemplary process for accessing an
intraosseous space of a patient in accordance with aspects of the
invention.
[0022] Features of the intraosseous devices and associated methods
according to aspects of the invention are described with reference
to the drawings, in which like reference numerals refer to like
parts throughout.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS OF THE
INVENTION
[0023] Vascular system access may be essential for treatment of
many serious diseases, chronic conditions and acute emergency
situations. Yet, many patients experience extreme difficulty
obtaining effective treatment because of inability to obtain or
maintain intravenous (IV) access. An intraosseous (IO) space
provides a direct conduit to a patent's vascular system and
systemic circulation. Therefore, IO access is an effective route to
administer a wide variety of drugs, other medications and fluids.
Rapid IO access offers great promise for almost any serious
emergency that requires vascular access to administer lifesaving
drugs, other medications and/or fluids when traditional IV access
is difficult or impossible.
[0024] An intraosseous space may generally be described as region
where cancellous bone and associated medullary cavity combine. Bone
marrow typically includes blood, blood forming cells, and
connective tissue found in an intraosseous space surrounded by
compact bone.
[0025] IO access may be used as a "bridge" (temporary fluid and
drug therapy) during emergency conditions until conventional IV
sites can be found and used. Conventional IV sites often become
available because fluids and/or medication provided via IO access
may stabilize a patient and expand veins and other portions of a
patient's vascular system. IO devices and associated procedures
incorporating teachings of the present disclosure may become
standard care for administering medications and fluids in
situations when IV access is difficult or not possible.
[0026] Intraosseous access may be used as a "routine" procedure
with chronic conditions that substantially reduce or eliminate
availability of conventional IV sites. Examples of such chronic
conditions may include, but are not limited to, dialysis patients,
patients in intensive care units and epilepsy patients.
Intraosseous devices and associated apparatus incorporating
teachings of the present disclosure may be quickly and safely used
to provide IO access to a patient's vascular system in difficult
cases such as status epilepticus to give medical personnel an
opportunity to administer crucial medications and/or fluids.
[0027] The term "driver" may be used in this application to include
any type of manual driver satisfactory for inserting a penetrator
assembly or an IO needle into selected portions of a patient's
vascular system. Various techniques may be satisfactorily used to
releasably engage or a penetrator assembly with manual drivers.
[0028] For some applications a manual driver may be securely
attached to a portion of an IO device or may be formed as an
integral component of an IO device. Various types of connectors may
also be used to releasably couple a manual driver with a penetrator
assembly. A wide variety of connectors and associated connector
receptacles, fittings and/or other types of connections with
various dimensions and configurations may be satisfactorily used to
engage a penetrator assembly with a manual driver.
[0029] For some applications a layer or coating (not expressly
shown) of an anticoagulant such as, but not limited to, heparin may
be placed on interior and/or exterior portions of a catheter or
cannula to prevent thrombotic occlusion of the catheter or cannula.
Anticoagulants may reduce platelet adhesion to interior surfaces of
the catheter or cannula and may reduce clotting time of blood
flowing into and through the catheter or cannula. Placing a layer
of an anticoagulant on the exterior of a catheter or cannula
adjacent to an associated tip may be helpful to prevent
clotting.
[0030] The term "fluid" may be used in this application to describe
any liquid including, but not limited to, blood, water, saline
solutions, IV solutions, plasma or any mixture of liquids,
particulate matter, dissolved medication and/or drugs appropriate
for injection into bone marrow or other insertion sites. The term
"fluid" may also be used within this patent application to include
body fluids such as, but not limited to, blood and cells which may
be withdrawn from an insertion site.
[0031] FIGS. 1A-3C show an exemplary intraosseous (IO) device 10 in
accordance with aspects of the invention. FIGS. 1A and 1B
respectively illustrate a prospective and an exploded view of the
intraosseous device 10. FIGS. 2A-2C respectively illustrate side
views of first and second bodies of the housing and of the hand
crank, as described below. FIGS. 3A-3C illustrate a plurality of
exemplary housings, as discussed in greater detail below.
[0032] The IO device 10 may include a driver comprising a housing
100 and a transmission at least partially disposed within the
housing 100. The transmission may include a first portion 210 and a
second portion 226. The second portion 226 may include a manual
actuator (e.g., a hand crank) that is at least partially disposed
outside of the housing 100. The IO device 10 may further include a
penetrator assembly 300 that may be releasably connected to the
first portion 210 of the transmission. The transmission may
transmit a force, which is applied manually to the manual actuator,
to the penetrator assembly 300 to rotate the penetrator assembly
300 relative to the housing 100 and to drive the penetrator
assembly 300 through bone (e.g., the proximal humerus, proximal
tibia, distal tibia, etc.) into an intraosseous space (not shown).
That is, the transmission may rotate the penetrator assembly 300
relative to the housing 100 to facilitate driving the penetrator
assembly 300 through bone into the intraosseous space while an
operator presses the IO device 10 through an insertion site.
[0033] According to aspects of the invention, the manually driven
transmission may obviate the need for a powered transmission, which
may lower production costs of the IO device 10 and thereby improve
patient access to life-saving IO devices 10. In addition, the
housing 100 of the IO device 10 may be shaped to improve an
operator's view of an insertion site on a patient. Further, the IO
device 10 may be rotated about a longitudinal direction of the
penetrator assembly 300 in accordance with operator preference such
that an operator may manually apply the force to the second portion
226 of the transmission using either the operator's left or right
hand. In addition, the torque and/or speed of the rotation of the
penetrator assembly 300 may be controlled by the operator based
upon, e.g., tactile/haptic feedback felt by the operator during
application of the force to the second portion 226 of the
transmission. Still further, the manually driven IO device 10 may
be quieter than powered devices.
[0034] The housing 100 may be divided into one or more bodies. For
example, the housing 100 may include a first body 110, a second
body 112, and/or a third body 114. The first body 110, second body
112, and/or third body 114 may be releasably connected. For
example, the first body 110, second body 112, and/or third body 114
may be snap fit together. The first body 110, second body 112,
and/or third body 114 may additionally or alternatively be
connected via fasteners (not shown) such as threads, nuts/bolts,
screws, etc. The first body 110, second body 112, and/or third body
114 may alternatively be fixedly connected. For example, the first
body 110, second body 112, and/or third body 114 may be fixed
together via an adhesive, weld, etc. The third body 114 may include
an opening 116. The opening 116 may have an inner diameter that is
greater than an outer diameter of the first portion 210 of the
transmission (e.g., an outer diameter of the shaft 212, described
below). The first portion 210 of the transmission may extend
through and beyond the opening 116 of the third body 114 for
connection with the penetrator assembly 300. The housing 100 may
include supports 130 that provide structural support to the housing
100. The supports 130 may be disposed within an interior of the
housing 100.
[0035] The housing 100 may include may include bearings 118 that
may support the first portion 210 and/or the second portion 226 of
the transmission such that the first portion 210 and/or the second
portion 226 of the transmission may rotate relative to the housing
100. The bearings 118 may be integrally formed with (i.e., integral
with) the housing 100 and may be formed of the same material that
comprises the housing 100. The bearings may alternatively be
distinct components. Distinct bearings may be formed of at least
some of the same materials as the housing 100 or may alternatively
be formed of at least one different material from the housing
100.
[0036] The bearings 118 may include tubular bearings 120 arranged
coaxially along a linear direction L that extends through the
housing 100. The opening 116 of the third body 114 of the housing
100 may also be arranged coaxially with the tubular bearings 120
along the linear direction L extending through the housing 100. The
tubular bearings 120 may include an inner circumferential surface
122. The inner circumferential surface 122 of the tubular bearings
120 may support the first portion 210 of the transmission such that
the first portion 210 of the transmission may rotate relative to
the housing 100. In embodiments not shown, a single tubular bearing
may support the first portion 210 of the transmission. An inner
diameter of the inner circumferential surface 122 of the tubular
bearings 120 may be larger than the outer diameter of the first
portion 210 of the transmission. The first portion 210 of the
transmission may extend through the tubular bearings 120. The inner
diameter of the inner circumferential surface 122 of the tubular
bearings 120 may be large enough to allow the first portion 210 of
the transmission to extend through the tubular bearings 120 and to
rotate within the tubular bearings 120, yet small enough to
restrict wobbling of the first portion 210 of the transmission.
[0037] The tubular bearings 120 may each comprise semi-circular
bearings surfaces 124 respectively provided on the first body 110
and the second body 112. The semi-circular bearing surfaces 124 may
be respectively arranged on the first body 110 and the second body
112 such that when the first body 110 and the second body 112 are
releasably connected the semi-circular bearing surfaces 124 are
united together to form the inner circumferential surface 122 of
the tubular bearings 120. The semi-circular bearing surfaces 124
may be respectively provided on the supports 130 of the first body
110 and the second body 112.
[0038] The bearings 118 may further include a cylindrical bearing
126 extending perpendicular to the linear direction L of the
housing 100. The cylindrical bearing 126 may support the second
portion 226 of the transmission such that the second portion 226 of
the transmission may rotate relative to the housing 100. For
example, the cylindrical bearing 126 may have an outer
circumferential surface 128. The cylindrical bearing 126 may be
provided within a space bounded by an inner circumferential surface
248 of the second portion 226 of the transmission such that the
outer circumferential surface 128 of the cylindrical bearing 126
rotatably supports the second portion 226 of the transmission. A
diameter of the outer circumferential surface 128 of the
cylindrical bearing 126 may be smaller than a diameter of the inner
circumferential surface 248 of the second portion 226 of the
transmission. The diameter of the outer circumferential surface 128
of the cylindrical bearing 126 may be small enough to allow the
inner circumferential surface 248 of the second portion 226 of the
transmission to fit around the outer circumferential surface 128 of
the transmission, yet large enough to restrict wobbling of the
second portion 226 of the transmission. In alternate embodiments
not shown, the second portion 226 of the transmission may include a
circumferential surface that may be provided within a space bounded
by an inner circumferential surface of the cylindrical bearing 126
such that the inner circumferential surface of the cylindrical
bearing 126 rotatably supports the second portion 226 of the
transmission. The cylindrical bearing 126 may be provided on the
first body 110 or the second body 112 of the housing 100. For
example, the cylindrical bearing 126 may be provided on the first
body 110.
[0039] The housing 100 may further include a first chamber 132, a
second chamber 134, and/or an opening 136 that may accommodate
and/or support the transmission. The first chamber 132 and/or the
second chamber 134 may accommodate and/or support at least part of
the first portion 210 of the transmission, as described below. The
first chamber 132 and/or the second chamber 134 may be provided on
the first body 110 or the second body 112 of the housing 100. In an
embodiment of the invention, the first chamber 132, the second
chamber 134, and the cylindrical bearing 126 may each be provided
on the same body (e.g., the first body 110) of the housing 100. The
opening 136 may be provided on either the first body 110 or the
second body 112 of the housing 100, and the second portion 226 of
the transmission may extend through the opening 136. The opening
136 may be provided on a different body (e.g., the second body 112)
of the housing 100 from the body of the housing 100 that includes
the first chamber 132, the second chamber 134, and/or the
cylindrical bearing 126.
[0040] The housing 100 may be formed of any suitable material, or
combination of materials, such as, e.g., plastics, metals,
composites, rubber, etc. The housing 100 may include ergonomic
portions 138 that may improve usability of the IO device 10 by,
e.g., improving an operator's grip on the IO device 10. The
ergonomic portions 138 may be textured. The ergonomic portions 138
may additionally or alternatively be formed of a material different
from materials forming other portions 140 of the housing 100. For
example, the housing 100 may include other portions 140 (e.g.,
structural regions) that are distinct from the ergonomic portions
138. The other portions 140 may be made of a first material and the
ergonomic portions 138 may be made of a second material. The first
material may be different from the second material. For example,
the first material may be a rubber material and the second material
may be plastic, metal, and/or composite material.
[0041] The housing 100 of the IO device 10 may be uniquely shaped
to suit operator preferences and/or for particular applications.
For example, according to an exemplary embodiment of the invention
depicted in FIG. 3A, the IO device 10 may include a circularly
shaped housing 101. More particularly, the circularly shaped
housing 101 may be a disc. The circularly shaped housing 101 may
include an outer circumferential surface 142, a central region 144,
and a side face 146. The first portion 210 of the transmission may
project from the outer circumferential surface 142 of the
circularly shaped housing 101. The second portion 226 of the
transmission may project from the side face 146 at the central
region 144. The ergonomic portions 138 may be arranged at the outer
circumferential surface 142.
[0042] As shown in FIG. 3B, the IO device 10 may include a
triangularly shaped housing 102. The triangularly shaped housing
102 may include a first side 148, a second side 150, and a third
side 152. The first portion 210 of the transmission may project
from the triangularly shaped housing 102 between the first side 148
and the third side 152. The triangularly shaped housing 102 may
also include a side face 154 and a central region 156. The second
portion 226 of the transmission may project from the side face 154
at the central region 156. The ergonomic portions 138 may be
arranged around the first side 148, the second side 150, and/or the
third side 152.
[0043] As shown in FIG. 3C, the IO device 10 may include an oval
shaped housing 103. The oval shaped housing 103 may include an oval
shaped outer peripheral surface 160, a central region 162, and a
side face 164. The first portion 210 of the transmission and may
project from the oval shaped outer peripheral surface 160 of the
oval shaped housing 103. The second portion 226 of the transmission
may project from the side face 164 at the central region 162. The
ergonomic portions 138 may be arranged at the oval shaped outer
peripheral surface 160.
[0044] FIGS. 1A-2C show details of embodiments of the transmission
of the IO device 10 having the housing 100. The transmission of the
IO device 10 may be utilized with any of the above-described
housing embodiments.
[0045] The transmission may be any system comprising, e.g., shafts,
gears, torque converters, etc. that may transmit the manually
applied force to the penetrator assembly 300 to rotate the
penetrator assembly 300 relative to the housing 100 and to drive
the penetrator assembly 300 through the bone and into the
intraosseous space. For example, the first portion 210 of the
transmission may include a shaft 212 arranged coaxially with the
linear direction L extending through the housing 100. The shaft 212
may include a first end 214, a second end 216, and a body 220
extending between the first end 214 and the second end 216. The
first end 214 of the shaft 212 may interface with the penetrator
assembly 300 to connect the transmission to the penetrator assembly
300 to transmit the manual force to the penetrator assembly 300.
The first end 214 of the shaft 212 may be keyed to connect to the
penetrator assembly 300 in a manner that allows the shaft 212 to
transmit rotational force to the penetrator assembly 300. For
example, the first end 214 of the shaft 212 may be five-sided. In
addition, the shaft 212 may be magnetic to facilitate connection
with the penetrator assembly 300. For example, a magnet 222 may be
embedded into the first end 214 of the shaft 212. Additionally or
alternatively, the shaft 212 may be formed of a magnetic material
such as metal.
[0046] The body 220 of the shaft 212 may be arranged through the
tubular bearings 120 of the housing 100 coaxially with the linear
direction L extending through the housing 100. Accordingly, shaft
212 may be rotatable relative to the housing 100.
[0047] The second end 216 of the shaft 212 may interface with the
second portion 226 of the transmission (e.g., with the gear 242,
described below) such that the manually applied force may be
transmitted from the second portion 226 of the transmission to
rotate the shaft 212 about the linear direction L extending through
the housing 100. For example, the second end 216 of the shaft 212
may include a gear 218, such as a helical gear. The gear 218 may be
accommodated within the second chamber 134 of the housing 100 such
that the gear 218 may freely rotate relative to the housing 100.
The gear 218 may mesh with the second portion 226 of the
transmission such that rotational force of the second portion 226
of the transmission may be transmitted to the gear 218 to rotate
the shaft 212. In addition, the first portion 210 of the
transmission may further include a support plate 224 held within
the first chamber 132 of the housing 100. The second end 216 of the
shaft 212 may be rounded and may be supported within the second
chamber 134 of the housing 100 by the support plate 224. For
example, the support plate 224 may support the second end 216 of
the shaft 212 to resist movement of the shaft 212 along the linear
direction L of the housing 100 when the penetrator assembly is
inserted into the insertion site.
[0048] The manual actuator may be a hand crank that may be manually
cranked by an operator to transfer rotational force to the first
portion 210 of the transmission. The hand crank may have a first
end 228, a second end 232, and an arm 250 extending between the
first end 228 and the second end 232. The first end 228 of the hand
crank may include a handle 230, which may be grasped by an operator
during application of the manual (rotational) force. The handle 230
may be integrally formed with the arm 250. Alternatively, the
handle 230 may be provided on a cylindrical bearing 252 of the arm
250 such that the handle 230 may be rotatable relative to the arm
250 to improve the usability of the hand crank.
[0049] The second end 232 of the hand crank may include a cylinder
234 having a top 236, a bottom 238, and an outer circumferential
surface 244 extending between the top 236 and the bottom 238. The
top 236 of the cylinder 234 may be provided outside of the interior
of the housing 100. The arm 250 of the hand crank may be attached
to the top 236 of the cylinder 234. For example, the arm 250 may be
integral with the top 236 of the cylinder 234. Alternatively, the
arm 250 may be fixed to the top 236 of the cylinder 234 via a
fastener (e.g., screw, bolt, etc.). The arm 250 may extend
angularly from the top 236 of the cylinder 234. For example, an
angle may be formed between an inner surface 254 of the arm 250 and
the outer circumferential surface 244 of the cylinder 234. The
angle may be greater than 90 degrees and the arm 250 may be capable
of 360-degree rotation without interference from the housing
100.
[0050] The bottom 238 of the cylinder 234 may be disposed within
the interior of the housing 100. The bottom 238 of the cylinder 234
may include a flange 240. The flange 240 may have an outer diameter
that is larger than an inner diameter of the opening 136 of the
housing 100. Accordingly, the flange 240 may hold the bottom 238 of
the cylinder 234 within the interior of housing 100 by preventing
removal of the bottom 238 of the cylinder 234 through the opening
136 of the housing 100. A top of the flange 240 may be a bearing
surface that may interface with the housing 100 in a manner that
facilitates rotation of the cylinder 234 relative to the housing
100. A bottom of the flange 240 may interface with the first
portion 210 of transmission. For example, the bottom of the flange
240 may form a gear 242 that may mesh with the gear 218 of the
shaft 212 of the first portion 210 of the transmission such that
rotational force may be transmitted between the gear 242 of the
bottom of the flange 240 and the gear 218 of the shaft 212 of the
first portion 210 of the transmission.
[0051] The hand crank may be rotated clockwise and/or counter
clockwise. The interface between the bottom of the flange 240 and
the first portion 210 of the transmission may be configured such
that the hand crank may alternately rotate the first portion 210 of
the transmission (and the penetrator assembly 300 attached thereto)
in both clockwise and counterclockwise directions. Alternatively,
the interface between the bottom of the flange 240 and the first
portion 210 of the transmission may be configured such that the
hand crank may only rotate the first portion 210 of the
transmission (and the penetrator assembly 300 attached thereto) in
a single direction (e.g., the clockwise direction). For example, in
embodiments not shown a ratchet may be provided between the hand
crank and the first portion 210 of the transmission whereby
rotational force of the hand crank may only be transmitted to the
first portion 210 of the transmission in a single direction to
cause the first portion 210 of the transmission to rotate only in,
e.g., the clockwise direction.
[0052] The inner circumferential surface 248 of the second portion
226 of the transmission that is rotatably supported by the
cylindrical bearing 126 of the housing 100, as described above, may
be provided within the cylinder 234. For example, the cylinder 234
may be hollow and a second hollow cylinder 246 may be provided
within an interior of the hollow cylinder 234. The inner
circumferential surface 248 of the second portion 226 of the
transmission may be the inner surface of the second hollow cylinder
246.
[0053] The outer circumferential surface 244 of the cylinder 234
may extend through, and be rotatably supported by, the opening 136
of the housing 100. An outer diameter of the outer circumferential
surface 244 may be smaller than the inner diameter of the opening
136 of the housing 100. The outer diameter of the outer
circumferential surface 244 may be small enough to extend through
the inner diameter of the opening 136 of the housing 100, yet large
enough to restrict wobbling of the second portion 226 of the
transmission.
[0054] FIGS. 4-7B show another IO device 10' in accordance with
aspects of the invention. FIG. 4 illustrates a prospective view of
the IO device 10'. FIG. 5 illustrates a side exploded view of the
IO device 10'. FIGS. 6A and 6B illustrate side views showing the
interiors of first and second bodies of the housing of the IO
device 10'. FIGS. 7A and 7B show views of the transmission of the
IO device 10'. In these figures, like elements (i.e., with respect
to the IO device 10) are referenced with like reference numerals
and therefore require no further description. Like reference
numerals in the other IO device 10' that include prime (') marks
denote corresponding elements of the IO device 10, but may have
different function and/or design as described below and/or as is
apparent from the drawings.
[0055] The IO device 10' may include a driver comprising a housing
100', and a transmission at least partially disposed within the
housing 100'. The transmission may include a first portion 210' and
a second portion 226'. The second portion 226' may include a manual
actuator (e.g., a hand crank) that is at least partially disposed
outside of the housing 100'. The IO device 10' may further include
the penetrator assembly 300, which may be releasably connected to
the first portion 210' of the transmission. The transmission may
transmit a force, which is applied manually to the manual actuator,
to the penetrator assembly 300 to rotate the penetrator assembly
300 relative to the housing 100' and to drive the penetrator
assembly 300 through bone (e.g., the proximal humerus, proximal
tibia, distal tibia, etc.) into an intraosseous space (not shown).
That is, the transmission may rotate the penetrator assembly 300
relative to the housing 100' to facilitate driving the penetrator
assembly 300 through bone into the intraosseous space while an
operator presses the IO device 10' through an insertion site.
[0056] According to aspects of the invention, the manually driven
transmission may obviate the need for a powered transmission, which
may lower production costs of the IO device 10' and thereby improve
patient access to life-saving IO devices 10'. In addition, the
housing 100' of the IO device 10' may be shaped to improve an
operator's view of an insertion site on a patient. Further, the IO
device 10' may be rotated about a longitudinal direction of the
penetrator assembly 300 in accordance with operator preference such
that an operator may manually apply the force to the second portion
226' of the transmission using either the operator's left or right
hand. In addition, the torque and/or speed of the rotation of the
penetrator assembly 300 may be controlled by the operator based
upon, e.g., tactile/haptic feedback felt by the operator during
application of the force to the second portion 226' of the
transmission. Still further, the manually driven IO device 10' may
be quieter than powered devices.
[0057] The housing 100' may be divided into one or more bodies. For
example, the housing 100' may include a first body 110' and a
second body 112'. The first body 110' and the second body 112' may
be releasably connected. For example, the first body 110' and the
second body 112' may be snap fit together. The first body 110' and
the second body 112' may additionally or alternatively be connected
via one or more fastener 111, such as threads, nuts/bolts, screws,
etc. For example, the second body 112' may include a hole 113
through which the fastener 111 may pass. The first body 110' may
include a threaded aperture 115 through which the fastener 111 may
be threadedly attached to connect the first body 110' and the
second body 112'. The first body 110' and the second body 112' may
alternatively be fixedly connected. For example, the first body
110' and the second body 112' may be fixed together via an
adhesive, weld, etc. The first body 110' and the second body 112'
may form an opening 116' when releasably connected together. The
housing 100' may include one or more supports 130' that provide
structural support to the housing 100'. The supports 130' may be
disposed within an interior of the housing 100'.
[0058] The housing 100' may include may include bearings 118' that
may support the first portion 210' and/or the second portion 226'
of the transmission such that the first portion 210' and/or the
second portion 226' of the transmission may rotate relative to the
housing 100'. The bearings 118' may be formed of the same material
that comprises the housing 100'. The bearings 118' may be
integrally formed with (i.e., integral with) the housing 100', or
may alternatively be distinct components. Distinct bearings (e.g.,
the tubular bearing 120' described below) may be formed of at least
some of the same materials as the housing 100', or may
alternatively be formed of at least one different material from the
housing 100'.
[0059] The bearings 118' may include one or more tubular bearing
120' arranged coaxially along a linear direction L that extends
through the housing 100'. The opening 116' of the housing 100' may
also be arranged coaxially with the tubular bearing 120' along the
linear direction L extending through the housing 100'. The tubular
bearing 120' may include an inner circumferential surface 122'. The
inner circumferential surface 122' of the tubular bearing 120' may
support the first portion 210' of the transmission such that the
first portion 210' of the transmission may rotate relative to the
housing 100'. For example, the penetrator assembly 300 may extend
through the tubular bearing 120' and the inner circumferential
surface 122' may support the penetrator assembly 300, which thereby
indirectly supports the first portion 210' of the transmission that
is fixed to the penetrator assembly 300. The penetrator assembly
300 may be arranged through the tubular bearing 120' of the housing
100' coaxially with the linear direction L extending through the
housing 100'. Accordingly, the penetrator assembly 300 may be
rotatable relative to the housing 100'. The tubular bearing 120'
may be distinct from the first body 110' and the second body 112'
and may be held within the opening 116'. An inner diameter of the
inner circumferential surface 122' of the tubular bearing 120' may
be larger than the outer diameter of the first portion 210' of the
transmission and/or than the penetrator assembly 300. The first
portion 210' of the transmission and/or the penetrator assembly 300
may extend through the tubular bearing 120'. The inner diameter of
the inner circumferential surface 122' of the tubular bearings 120'
may be large enough to allow the first portion 210' of the
transmission and/or the penetrator assembly 300 to extend through
the tubular bearing 120' and to rotate within the tubular bearing
120', yet small enough to restrict wobbling of the first portion
210' of the transmission and/or of the penetrator assembly 300.
[0060] The bearings 118' may further include a cylindrical bearing
126' extending perpendicular to the linear direction L of the
housing 100'. The cylindrical bearing 126' may support the second
portion 226' of the transmission such that the second portion 226'
of the transmission may rotate relative to the housing 100'. The
cylindrical bearing 126' may be provided on the first body 110' or
the second body 112' of the housing 100'. For example, the
cylindrical bearing 126' may be provided on the second body
112'.
[0061] The cylindrical bearing 126' may have an outer
circumferential surface 128' that extends perpendicular to the
linear direction L of the housing 100' beyond an exterior of the
second body 112'. The outer circumferential surface 128' may
rotatably support the second portion 226' of the transmission. For
example, the outer circumferential surface 128' may rotatably
support an inner circumferential surface 248' of the second portion
226' of the transmission. The cylindrical bearing 126' may be
provided within a space bounded by the inner circumferential
surface 248' of the second portion 226' of the transmission such
that the outer circumferential surface 128' of the cylindrical
bearing 126' rotatably supports the second portion 226' of the
transmission. A diameter of the outer circumferential surface 128'
of the cylindrical bearing 126' may be smaller than a diameter of
the inner circumferential surface 248' of the second portion 226'
of the transmission. The diameter of the outer circumferential
surface 128' of the cylindrical bearing 126' may be small enough to
allow the inner circumferential surface 248' of the second portion
226' of the transmission to fit around the outer circumferential
surface 128' of the cylindrical bearing 126', yet large enough to
restrict wobbling of the second portion 226' of the transmission.
The cylindrical bearing 126' may further include an inner
circumferential surface 129. The inner circumferential surface 129
may bound an inner space within the cylindrical bearing 126' that
may rotatably receive part of the second portion 226' of the
transmission (e.g., the shaft 255, described below).
[0062] The housing 100' may further include a first chamber 132'
and/or a second chamber 134' that may accommodate and/or support
the transmission. The first chamber 132' and/or the second chamber
134' may accommodate and/or support at least parts of the first
portion 210' and the second portion 226' of the transmission, as
described below. The first chamber 132' and/or the second chamber
134' may be provided on the first body 110' or the second body 112'
of the housing 100'. For example, the first chamber 132' may be
provided on the first body 110' and the second chamber 134' may be
provided on the second body 112'. The first chamber 132' and the
second chamber 134' may be circularly shaped.
[0063] The housing 100' may be formed of any suitable material, or
combination of materials, such as, e.g., plastics, metals,
composites, rubber, etc. The housing 100' may include ergonomic
portions 138' that may improve usability of the IO device 10' by,
e.g., improving an operator's grip on the IO device 10'. The
ergonomic portions 138' may be textured. The ergonomic portions
138' may be grooves. The ergonomic portions 138' may additionally
or alternatively be formed of a material different from materials
forming other portions 140' of the housing 100'. For example, the
housing 100' may include other portions 140' (e.g., structural
regions) that are distinct from the ergonomic portions 138'. The
other portions 140' may be made of a first material and the
ergonomic portions 138' may be made of a second material. The first
material may be different from the second material. For example,
the first material may be a rubber material and the second material
may be plastic, metal, and/or composite material.
[0064] The housing 100' of the IO device 10' may be uniquely shaped
to suit operator preferences and/or for particular applications.
For example, according to an exemplary embodiment of the invention
depicted in, e.g., FIG. 4, the housing 100' of the IO device 10'
may be shaped similar to the handle of a screw driver.
Alternatively, the IO device 10' may include any of the housings
depicted in the embodiments shown in FIGS. 1A-3C and described
above.
[0065] FIGS. 5, 7A and 7B show details of embodiments of the
transmission of the IO device 10'. The transmission of the IO
device 10' may be utilized with any of the above-described housing
embodiments.
[0066] The transmission may be any system comprising, e.g., shafts,
gears, torque converters, etc. that may transmit the manually
applied force to the penetrator assembly 300 to rotate the
penetrator assembly 300 relative to the housing 100' and to drive
the penetrator assembly 300 through the bone and into the
intraosseous space. For example, the first portion 210' of the
transmission may include a gear 218', such as a bevel gear. The
gear 218' may interface with the penetrator assembly 300 to connect
the transmission to the penetrator assembly 300 to transmit the
manual force to the penetrator assembly 300. For example, the gear
218' may be integrally formed with the penetrator assembly 300. The
gear 218' may alternatively be a distinct component that may be
fixedly or removably attached to the penetrator assembly 300 such
that the gear 218' may transmit the manual force to the penetrator
assembly 300. For example, the gear 218' may be threadedly attached
to the penetrator assembly 300. The gear 218' may be attached to
the penetrator assembly 300 via a keyed interface, an adhesive,
and/or a magnet. The gear 218' may interface with the second
portion 226' of the transmission (e.g., with the gear 242',
described below) such that the manually applied force may be
transmitted from the second portion 226' of the transmission to
rotate the gear 218' about the linear direction L extending through
the housing 100'. The gear 218' may be accommodated within the
first chamber 132' and/or the second chamber 134' of the housing
100' such that the gear 218' may freely rotate relative to the
housing 100'. The gear 218' may mesh with the second portion 226'
of the transmission such that rotational force of the second
portion 226' of the transmission may be transmitted to the gear
218' to rotate the penetrator assembly 300.
[0067] The manual actuator may be a hand crank that may be manually
cranked by an operator to transfer rotational force to the first
portion 210' of the transmission. The hand crank may have a first
end 228', a second end 232', and an arm 250' extending between the
first end 228' and the second end 232'. The first end 228' of the
hand crank may include a handle 230', which may be grasped by an
operator during application of the manual (rotational) force. The
handle 230' may be integrally formed with the arm 250'.
Alternatively, the handle 230' may be provided on a cylindrical
bearing 252' of the arm 250' such that the handle 230' may be
rotatable relative to the arm 250' to improve the usability of the
hand crank. A fastener 253 may fasten the handle 230' to the
cylindrical bearing 252'.
[0068] The second end 232' of the hand crank may include a cylinder
234' having a top 236', a bottom 238', and an outer circumferential
surface 244' extending between the top 236' and the bottom 238'.
The top 236' of the cylinder 234' may be provided outside of the
interior of the housing 100'. The arm 250' of the hand crank may be
attached to the top 236' of the cylinder 234'. For example, the arm
250' may be integral with the top 236' of the cylinder 234'.
Alternatively, the arm 250' may be fixed to the top 236' of the
cylinder 234' via a fastener (e.g., screw, bolt, etc.). In
embodiments not shown, the arm 250' may extend angularly from the
top 236' of the cylinder 234'. For example, an angle may be formed
between an inner surface of the arm 250' and the outer
circumferential surface 244' of the cylinder 234'. The angle may be
greater than 90 degrees and the arm 250' may be capable of
360-degree rotation without interference from the housing 100'.
[0069] The second portion 226' of the transmission may include a
gear 242', such as a bevel gear, that may mesh with the gear 218'
of the first portion 210' of the transmission such that rotational
force may be transmitted between the gear 242' and the gear 218'.
The gear 242' may be coupled to the hand crank such that an
operator may transmit rotational force from the hand crank to the
gear 242'. For example, the gear may include a shaft 255 that may
be received within the inner space bound by the inner
circumferential surface 129 of the cylindrical bearing 126'. The
shaft 255 may be keyed and may fit within a complementary keyed
region within the hollow interior of the cylinder 234'. A fastener
257 may fasten to the shaft 255 and the cylinder 234'.
[0070] The hand crank may be rotated clockwise and/or counter
clockwise. The interface between the first portion 210' and the
second portion 226' of the transmission may be configured such that
the hand crank may alternately rotate the first portion 210' of the
transmission (and the penetrator assembly 300 attached thereto) in
both clockwise and counterclockwise directions. Alternatively, the
first portion 210' and the second portion 226' of the transmission
may be configured such that the hand crank may only rotate the
first portion 210' of the transmission (and the penetrator assembly
300 attached thereto) in a single direction (e.g., the clockwise
direction). For example, in embodiments not shown a ratchet may be
provided between the hand crank and the first portion 210' of the
transmission whereby rotational force of the hand crank may only be
transmitted to the first portion 210' of the transmission in a
single direction to cause the first portion 210' of the
transmission to rotate only in, e.g., the clockwise direction.
[0071] The inner circumferential surface 248' of the second portion
226' of the transmission that is rotatably supported by the
cylindrical bearing 126' of the housing 100', as described above,
may be provided within the cylinder 234'. In addition, the shaft
255 may extend through and be rotatably supported by the inner
space of the cylindrical bearing 126'. A diameter of the inner
circumferential surface 129 of the cylindrical bearing 126' may be
larger than a diameter of the shaft 255 of the second portion 226'
of the transmission. The diameter of the inner circumferential
surface 129 of the cylindrical bearing 126' may be large enough to
allow the shaft 255 of the second portion 226' of the transmission
to fit within the inner space bounded by the inner circumferential
surface 129, yet small enough to restrict wobbling of the shaft 255
of the second portion 226' of the transmission.
[0072] FIGS. 8A-8C show an exemplary embodiment of the penetrator
assembly 300 according to aspects of the invention. The penetrator
assembly 300 may be included with either or both of the
above-described IO devices 10, 10'. The penetrator assembly 300 may
include a connector 310, an associated hub 324, an outer penetrator
330, and an inner penetrator 334. The outer penetrator 330 may
include, e.g., a cannula, hollow tube, or hollow drill bit. The
inner penetrator 334 may include, e.g., a stylet or trocar. Various
types of stylets and/or trocars may be disposed within the outer
penetrator 330.
[0073] The connector 310 may connect the penetrator assembly 300 to
the transmission. For some applications, connector 310 may be
described as having a generally cylindrical configuration defined
in part by a first end 312 and a second end 316. Exterior portions
of the connector 310 may include an enlarged tapered portion
adjacent to first end 312. A plurality of longitudinal ridges 318
may be formed on the exterior of connector 310 to allow an operator
to grasp associated penetrator assembly 300 during attachment with
the shaft 212. Longitudinal ridges 318 also allow connector 310 to
be grasped for disengagement from hub 324 when outer penetrator 330
has been inserted into bone and associated bone marrow.
[0074] The first end 312 of the connector 310 may include an
opening 314 sized to receive portions of the shaft 212 therein. A
magnet (not shown) may be disposed within the opening 314 to
attract the shaft 212 to the opening 314. A plurality of webs 320
may extend radially outward from opening 314. The webs 320
cooperate with each other to form a plurality of openings 322
adjacent to first end 312. Opening 314 and openings 322 cooperate
with each other to form portions of a connector receptacle.
[0075] Second end 316 of connector 310 may include an opening (not
expressly shown) sized to receive first end 326 of hub 324,
therein. Threads may be formed in the opening adjacent to second
end 316 of connector 310. Such threads may be used to releasably
attach connector 310 with threads disposed adjacent to a first end
326 of the hub 324.
[0076] The first end 326 of hub 324 may have a generally
cylindrical pin type configuration compatible with releasable
engagement with second end 316 of connector 310. For some
applications first end 326 and threads may provide a portion of a
Luer lock connection. Various types of Luer lock connections may be
formed on the first end 326 of hub 324 for use in to releasably
engage tubing and/or other medical devices (not expressly shown)
with hub 324 after IO device 10 had been inserted into bone marrow
at a target area and inner penetrator 334 removed from outer
penetrator 330.
[0077] For some applications outer penetrator 330 may be described
as a generally elongated tube sized to receive inner penetrator 334
therein. Portions of inner penetrator 334 may be slidably disposed
within a longitudinal passageway (not expressly shown) extending
through outer penetrator 330. The outside diameter of inner
penetrator 334 and the inside diameter of the longitudinal
passageway may be selected such that inner penetrator 334 may be
slidably disposed within outer penetrator 330.
[0078] A tip 332 of the outer penetrator 330 and/or a tip 336 of
inner penetrator 334 may be operable to penetrate bone and
associated bone marrow. The configuration of tips 332 and/or 336
may be selected to penetrate a bone or other body cavities with
minimal trauma. Tip 336 of inner penetrator 334 may be trapezoid
shaped and may include one or more cutting surfaces. In one
embodiment outer penetrator 330 and inner penetrator 334 may be
ground together as one unit during an associated manufacturing
process. Providing a matching fit allows respective tips 332 and
336 to act as a single drill, which facilitates insertion and
minimizes damage as portions of penetrator assembly 300 are
inserted into a bone and associated bone marrow.
[0079] Inner penetrator 334 may also include a longitudinal groove
(not expressly shown) that runs along the side of inner penetrator
334 to allow bone chips and/or tissues to exit an insertion site as
penetrator assembly 300 is drilled deeper into an associated bone.
Outer penetrator 330 and inner penetrator 334 may be formed from
stainless steel, titanium or other materials of suitable strength
and durability to penetrate bone.
[0080] For some applications a depth control limiter incorporating
teachings of the present disclosure, such as collar 338, may be
disposed on and engaged with exterior portions of outer penetrator
330. The collar 338 may sometimes be referred to as a "depth
control limiter." Other examples of depth control limiters which
may be used, or adapted for use, with the present invention may be
found, e.g., in U.S. Pat. No. 8,998,848, the contents of which is
hereby expressly incorporated by reference herein in its
entirety.
[0081] For some embodiments collar 338 may have a generally
elongated, hollow configuration compatible with engaging the
outside diameter of outer penetrator 330. A first end (not
expressly shown) of collar 338 may be installed over exterior
portions of outer penetrator 330 and disposed within adjacent
portions of hub 324. A second end 340 of collar 338 may extend a
selected distance from a second end 328 of hub 324. Various
techniques such as, but not limited to, press fitting may be used
to install collar 338 on exterior portions of outer penetrator
330.
[0082] The resulting spacing between second end 328 of hub 324 and
second end 340 of collar 338 may limit depth of penetration of
outer penetrator 330 into bone and associated bone marrow. Second
end 328 of hub 324 and second end 340 of collar 338 may cooperate
with each other to provide a depth control limiter for associated
IO device 10 or penetrator assembly 300. Collar 338 may be formed
from various materials including stainless steel, titanium or other
materials used to form outer penetrator 330.
[0083] Collar 338 will generally be securely engaged with the
exterior of outer penetrator 330. As a result, outer penetrator 330
and collar 338 will generally rotate with each other when force is
applied via the transmission. For other applications portions of
the IO device 10 and an associated depth control limiter may be
operable to rotate relative to each other during insertion of the
IO device 10 into bone marrow adjacent to a selected insertion
site.
[0084] Hub 324 may be used to stabilize the penetrator assembly 300
during insertion of an associated penetrator into a patient's skin,
soft tissue and adjacent bone at a selected insertion site. Hub 324
may also be used as a handle to manipulate outer penetrator 330 or
remove outer penetrator 330 from a target area. First end 326 of
hub 324 may be operable for releasable engagement or attachment
with associated connector 310.
[0085] Passageway (not shown) may extend from first end 326 through
second end 328. The inside diameter of the passageway may be
selected to securely engage the outside diameter of inner
penetrator 334. The dimensions and configuration of passageway may
be selected to maintain associated outer penetrator 330 engaged
with hub 324.
[0086] Second end 328 of hub 324 may have a size and configuration
compatible with an insertion site for an associated penetrator
assembly 300.
[0087] Guide mechanisms and/or stabilizers (not shown) may be
provided when the IO device 10 is inserted into a patient, to guide
and/or stabilize the IO device 10 during insertion. Examples of
such guide mechanisms and/or stabilizers that may be used, or
adapter for use, with the present invention may be found in U.S.
Pat. Nos. 9,839,740 and 8,974,410, which are each hereby expressly
incorporated by references herein in their entirety.
[0088] FIG. 9 illustrates an exemplary process 400 for accessing an
intraosseous space of a patient in accordance with aspects of the
invention. At a first step 401, the process 400 may include
providing an IO device 10 (or the other IO device 10'). The IO
device 1040 device 10' may include aspects of any of the
above-described embodiments. For example, the IO device 10 may
include the housing 100 and the transmission at least partially
disposed within the housing 100. The transmission may include the
first portion 210 and the second portion 226. The IO device 10 may
further include the penetrator assembly 300 releasably connected to
the first portion 210 of the transmission.
[0089] At a second step 402, the process 400 may include driving
the penetrator assembly 300 through bone into the intraosseous
space of the patient. Driving the penetrator assembly 300 through
the bone and into the intraosseous space may include manually
applying a first force to the housing 100. The first force may
direct the IO device 10 towards an insertion site on the patient.
The insertion site may be disposed on a patient at, for example,
the proximal humerus, the proximal tibia, the distal tibia, etc. An
operator may grasp the housing 100 with one hand and press the
housing 100 towards the insertion site. Driving the penetrator
assembly 300 through the bone and into the intraosseous space may
further include manually applying a second force, concurrently with
manually applying the first force, to the second portion 226 of the
transmission and transmitting the second force to the penetrator
assembly 300 to rotate the penetrator assembly 300 relative to the
housing 100. For example, the operator may apply the manual force
to the second portion 226 of the transmission (e.g., to the handle
230 of the hand crank) to rotate the hand crank and thereby rotate
the penetrator assembly 300, as described above. Upon completion of
driving the penetrator assembly 300 though the bone and into the
intraosseous space, the penetrator assembly 300 may be removed from
the first portion 210 of the transmission permitting access to the
intraosseous space to, e.g., inject fluids into the patient in a
known manner.
[0090] The many features and advantages of the IO devices and
methods described herein are apparent from the detailed
specification, and thus, the claims cover all such features and
advantages within the scope of this application. Further, numerous
modifications and variations are possible. As such, it is not
desired to limit the IO devices to the exact construction and
operation described and illustrated and, accordingly, all suitable
modifications and equivalents may fall within the scope of the
claims.
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